Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation

Maxillary Cyst Clinical Trial

Official title:

Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03265795
• Other study ID #: maxillary reconstruction
• Status: Not yet recruiting
• Phase: N/A
• First received: August 27, 2017
• Last updated: August 29, 2017
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: Mohamed Zain, DDS
• Phone: 00201003363809
• Email: m_zain_89[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable.

Reconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: July 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age of patients from 15 to 60 years old.

2. Patients with unilateral maxillary lesion encroaching maxillary sinus.

3. Dentulous or edentulous patients.

4. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

Exclusion Criteria:

1. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).

2. Patients with bilateral maxillary lesions.

3. Children under 15 years old.

Related Conditions & MeSH terms

• Maxillary Cyst

Intervention

Device:
• Poly Ether Ether Ketone PSI (patient specific implant).
reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. — View Citation

Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagrèze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. — View Citation

Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral health related quality of life	OHIP-49 questionaire	4 months